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CDM
Introduction
What We Offer
Business Need
Mithas Schools of Thoughts
 
Oracle Pharmaceutical Applications (OLS)
Oracle Clinical
Thesaurus Management System
MedDRA
WHO Drug
 
1 MedDRA stands for Medical Dictionary of Regulatory Affairs
2 Standard dictionary for Adverse Events and mandated for use in SAE reporting by the US FDA and EMEA
3 Maintained by Northrop Grumman, formerly TRW, via an awarded contract by an internal consortium of regulatory agencies and pharmaceutical companies.
4 The MSSO division of Northrop Grumman maintains the MedDRA dictionary and sells subscriptions
5 Updated every 6 months, with releases ending in .0 for March releases and .1 for Sep releases
6 MedDRA primarily contains 5 levels

SOC
System Organ Class, this is the most general level of classifying an AE

HLGT
High Level Group Term

HLT
High Level Term

PT
Preferred Term

LLT
Lowest Level Term (This is usually the term coded against).
7 SMQs, or Standard MedDRA Queries, as of release 9.0 which allow “broad” and “narrow” conditionally based grouping of terms (mostly PTs) by special general disease/indication categories.
 
 
Clinical Research
CDM – Data Management System for Clinical Research
PGDCR / MS in Clinical Research
LIMS - Laboratory Information Management Systems
Batch III PGDCR starting on 19th January 2009.
 
 
 
 
We have landed at our new CRO facility, for a sparkling start
 
 
 
 
Autoscribe UK has appointed Mithas Labs to further expand its network of business partners offering pre-sales and post-sales services for its successful LIMS, scientific and business software solutions and implementation across India.
 
 
 
 
Mithas Labs has chosen Oracle Clinical for CDM License.
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